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Thd Slide One Thd Opti-Fiber (Evo/Bt)

by Thd SpA

Thd Slide One Thd Opti-Fiber (Evo/Bt) (880018) is a fibreoptic light cable (FDA Class II; FDA product code JAF, Monitor, Ultrasonic, Nonfetal) made by Thd SpA, cleared under FDA 510(k) K090009 on 28 Jan 2009 and listed in FDA GUDID since 9 Sep 2022 (UDI-DI 18033737710781), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K090009

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number18033737710781 UDI-DI Date9 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK090009 Date28 Jan 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090009 decided 28 Jan 2009 Active
  • FDA GUDID UDI-DI 18033737710781 listed 9 Sep 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K090009
  2. Listed FDA GUDID 18033737710781

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Thd Slide One
Generic name
Fibreoptic light cable, reusable
Model / Ref / Catalog
THD OPTI-FIBER (EVO/BT), 880018
Primary DI / UDI-DI
18033737710781
510(k) Number
FDA product code
JAF
GMDN term
Fibreoptic light cable, reusable
Device class
Class II
Regulation number
892.1540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)